Anchor magazine

ABSTRACT

Apparatus is provided, the apparatus comprising (i) a housing (22, 222), shaped to define a channel (24, 224) having an anchor-storage zone (26, 226) and an opening (28, 228) configured to provide access for an anchor driver (60) to the anchor-storage zone; (ii) a tissue anchor (40), stored in the anchor-storage zone and slidable through the channel; and (iii) a retaining member (30, 230). The retaining member (a) has a retaining state in which the retaining member is configured to retain the tissue anchor in the anchor-storage zone, and (b) is configured, by moving in response to a proximally-directed force applied to the tissue anchor, to allow the tissue anchor to leave the anchor-storage zone in response to the proximally-directed force. The proximally-directed force is greater than a pre-determined threshold force. Other embodiments are described.

CROSS-REFERENCES TO RELATED APPLICATIONS

The present application is a US National Phase of PCT applicationIL2014/050914 to Zipory et al., which published as WO 2015/059699, andwhich claims priority from US Provisional Patent Application U.S.61/894,486 to Zipory et al., entitled “Anchor Magazine”, filed Oct. 23,2013, which is incorporated herein by reference.

The present application is related to PCT Patent ApplicationIL2013/050861 to Herman et al., entitled “Percutaneous tissue anchortechniques”, filed on Oct. 23, 2013, which published as WO 2014/064695,and PCT Patent Application IL2013/050860 to Sheps et al., entitled“Controlled steering functionality for implant-delivery tool”, filed onOct. 23, 2013, which published as WO 2014/064694, both of which areincorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates in general to handling of tissue anchors.More specifically, the present invention relates to devices andtechniques for handling of a plurality of tissue anchors, and the usethereof at a heart valve of a patient.

BACKGROUND

Tissue anchors are placed intracorporeally so as to anchor implants to atissue of a subject. Typically, this intracorporeal placementnecessitates that the tissue anchors are small, e.g., having a greatestdimension (e.g., a length) of less than 11 mm and/or a maximum width of3 mm. It is therefore typically advantageous to provide devices andtechniques to facilitate handling of the tissue anchors.

SUMMARY OF THE INVENTION

An anchor-handling device is configured to facilitate handling of one ormore tissue anchors. The anchor-handling device retains the anchorswithin an anchor-storage zone of a channel defined by a housing until atool such as an anchor driver is used to retrieve the anchor. The toolis advanced through the channel, coupled to the anchor, and removedproximally out of the channel with the anchor. The anchor-handlingdevice is configured to release (e.g., dispense) the anchor only when aproximally-directed force applied by the tool to the anchor is greaterthan a pre-defined threshold force (i.e., is sufficient), so as toprevent inadvertent exit of the anchor.

A retaining member is configured to retain the tissue anchor in theanchor-storage zone, typically by obstructing exit of the tissue anchor.The sufficient proximally-directed force moves the retaining member outof the way of the anchor, e.g., by moving the anchor to push theretaining member out of the way. Typically, an inhibitor inhibitsmovement of the retaining member, thereby configuring the retainingmember to move out of the way of the anchor only in response to thesufficient proximally-directed force.

For some applications, the anchor-handling device is used in combinationwith a multi-component tubular system for transcatheter delivery of animplant, e.g., to facilitate sequential delivery of a plurality ofanchors to the implant via the system.

There is therefore provided, in accordance with an application of thepresent invention, apparatus for use with an anchor driver, theapparatus including:

a housing, shaped to define a channel having an anchor-storage zone anda proximal opening configured to provide access for the anchor driver tothe anchor-storage zone;

a tissue anchor, stored in the anchor-storage zone and slidable throughthe channel; and

a retaining member:

-   -   having a retaining state in which the retaining member is        configured to retain the tissue anchor in the anchor-storage        zone, and    -   being configured, by moving in response to a proximally-directed        force applied to the tissue anchor, to allow the tissue anchor        to leave the anchor-storage zone in response to the        proximally-directed force, the proximally-directed force being        greater than a pre-determined threshold force.

In an application, the apparatus is configured such that after removalof the tissue anchor from the housing, a distally-directed forcerequired to return the apparatus to the retaining state is more thantwice as great as the threshold force.

In an application, the retaining member is configured such that thethreshold force is 300-1500 grams force.

In an application, the tissue anchor has a mass, and the retainingmember is configured such that the threshold force, measured in gramsforce, is 1000-150,000 times greater than the mass of the tissue anchor,measured in grams.

In an application, the apparatus further includes an inhibitor,configured to configure the retaining member to (i) retain the tissueanchor in the anchor-storage zone, and (ii) to allow the tissue anchorto leave the anchor-storage zone in response to the proximally-directedforce.

In an application, the tissue anchor is dimensioned to fit snugly in theanchor-storage zone.

In an application, the apparatus further includes a multi-componenttubular system for transcatheter implantation of an implant into asubject, the implant configured to be anchored to tissue of the subjectusing the tissue anchor, and the housing being coupled to a component ofthe multi-component tubular system.

In an application, the component of the multi-component tubular systemincludes a stand, and the housing is coupled to the stand.

In an application, the multi-component tubular system defines a proximalport through which the anchor is introducible, and the housing iscoupled to the component of the multi-component tubular system such thatthe proximal opening of the housing is disposed between 1 and 40 cm fromthe port of the multi-component tubular system.

In an application, the multi-component tubular system defines a proximalport through which the anchor is introducible, and the housing iscoupled to the component of the multi-component tubular system such thatthe proximal opening of the housing faces generally the same directionas the port of the multi-component tubular system.

In an application:

the housing is configured to define a plurality of channels, each of theplurality of channels having a respective anchor-storage zone and arespective proximal opening, and

the apparatus includes a plurality of tissue anchors, slidable through arespective channel and configured to be stored in a respectiveanchor-storage zone.

In an application, the apparatus includes a plurality of retainingmembers, each retaining member configured to retain a respective tissueanchor in the respective anchor-storage zone, and to allow therespective tissue anchor to leave the respective anchor-storage zone inresponse to a proximally-directed force applied to the respective tissueanchor.

In an application, in the retaining state, at least a portion of theretaining member obstructs proximal movement of the tissue anchor bybeing disposed within the channel.

In an application, the apparatus further includes the anchor driver, andin the retaining state, the anchor driver is slidable through thechannel and lockable to the tissue anchor while at least the portion ofthe retaining member obstructs proximal movement of the tissue anchor bybeing disposed within the channel.

In an application, in the retaining state, the anchor driver is slidablethrough the channel such that a part of the anchor driver becomespositioned between a part of the tissue anchor and a part of theretaining member, and the anchor driver is lockable to the tissue anchoronly while the part of the anchor driver is positioned between the partof the tissue anchor and the part of the retaining member.

In an application:

the tissue anchor includes a core, a tissue-engaging member coupled to adistal side of the core, and a coupling head coupled to a proximal sideof the core, and

in the retaining state, at least the portion of the retaining memberthat obstructs the proximal movement of the tissue anchor obstructs theproximal movement of the tissue anchor by engaging the core.

In an application:

the housing is shaped to define a chamber that is in fluid communicationwith the channel,

at least part of the retaining member is configured to slide within thechamber in response to the proximally-directed force applied to thetissue anchor.

In an application, a first end of the chamber is in fluid communicationwith the channel, the housing defines a chamber opening of the chamberat a second end of the chamber, the portion of the retaining memberincludes a first portion of the retaining member, and the retainingmember is configured such that, in response to the proximally-directedforce applied to the tissue anchor, a second portion of the retainingmember moves out of the chamber opening.

In an application, the retaining member is configured such that, inresponse to the proximally-directed force applied to the tissue anchor,a second portion of the retaining member moves out of the housing.

In an application, the apparatus is configured such that after removalof the tissue anchor from the housing, a distally-directed forcerequired to return the apparatus to the retaining state is more thantwice as great as the threshold force.

In an application, the retaining member includes a pin, configured toslide through the chamber.

In an application:

the housing is shaped to define a cavity that is in fluid communicationwith the chamber,

at least a portion of the retaining member is resilient,

the retaining member is shaped to define a detent,

in the retaining state, the resilience of at least the portion of theretaining member holds the detent within the cavity, and

the retaining member is configured to deform in response to theproximally-directed force applied to the tissue anchor, such that thedetent exits the cavity.

In an application:

the cavity includes a first cavity,

the housing is shaped to define a second cavity that is in fluidcommunication with the chamber, and

the apparatus is dimensioned such that when the retaining member allowsthe tissue anchor to leave the anchor-storage zone, further proximalmovement of the retaining member causes the detent to move into thesecond cavity.

In an application, the second cavity is larger in at least one dimensionthan the first cavity.

In an application, the second cavity is differently shaped to the firstcavity.

In an application, the second cavity and the detent are dimensioned suchthat when the detent is disposed within the second cavity, adistally-directed force required to return the apparatus to theretaining state is more than twice as great as the threshold force.

In an application, at least a portion of the pin is dimensioned to slidesnugly through the chamber.

In an application, the apparatus further includes an inhibitor tonguehaving a pin-contacting portion that is in contact with the pin, andconfigured to (i) inhibit the pin from sliding through the chamber inresponse to a sub-threshold force, and (ii) to allow the pin to slidethrough the chamber in response to the proximally-directed force appliedto the tissue anchor.

In an application:

the pin is shaped to define a cavity,

at least a portion of the inhibitor tongue is resilient,

in the retaining state, the resilience of at least the portion of theinhibitor tongue holds the pin-contacting portion within the cavity, and

the inhibitor tongue is configured to deform in response to theproximally-directed force applied to the tissue anchor, such that thepin-contacting portion exits the cavity.

In an application:

the cavity includes a first cavity.

the pin is shaped to define a second cavity,

the apparatus is dimensioned such that when the retaining member allowsthe tissue anchor to leave the anchor-storage zone, further proximalmovement of the retaining member causes the pin-contacting portion tomove into the second cavity.

In an application, the second cavity is larger in at least one dimensionthan the first cavity.

In an application, the second cavity is differently shaped to the firstcavity.

In an application, the second cavity and the pin-contacting portion aredimensioned such that when the pin-contacting portion is disposed withinthe second cavity, a distally-directed force required to return theapparatus to the retaining state is more than twice as great as thethreshold force.

In an application, the chamber is in fluid communication with thechannel at a distal end of the chamber, and has a proximal-distallongitudinal axis that is disposed at between 5 and 30 degrees from aproximal-distal longitudinal axis of the channel.

In an application, the proximal-distal longitudinal axis of the chamberis disposed at between 5 and 20 degrees from the proximal-distallongitudinal axis of the channel

In an application, the proximal-distal longitudinal axis of the chamberis disposed at between 11 and 14 degrees from the proximal-distallongitudinal axis of the channel.

In an application, a central longitudinal axis of the chamber isparallel with a central longitudinal axis of the channel.

In an application, the tissue anchor is dimensioned to fit snuglythrough the channel.

In an application, the tissue anchor includes a core, a tissue-engagingmember coupled to a distal side of the core, and a coupling head, thecore is dimensioned to fit snugly through the channel, and thetissue-engaging member is dimensioned so as to not touch the housingwhen the tissue anchor moves through the channel.

In an application, the apparatus further includes the anchor driver.

In an application, the anchor driver includes:

at a distal end thereof, an anchor-engaging head introducible throughthe opening of the housing and actuatable to be reversibly coupled tothe tissue anchor;

at a proximal end thereof, a handle including an adjuster configured toactuate the anchor-engaging head; and

a flexible shaft:

-   -   disposed between the distal end of the anchor driver and the        proximal end of the anchor driver,    -   having a length of 50-250 cm, and    -   configured to be transcatheterally advanced through vasculature        of a subject.

In an application, the opening of the housing is rotationallyasymmetrical, a transverse cross-section of the anchor-engaging head isrotationally asymmetrical, and the opening limits a range of rotationalorientations of the anchor-engaging head with respect to the opening inwhich the anchor-engaging head is introducible through the opening.

In an application, the opening of the housing and the transversecross-section of the anchor-engaging head each have the shape of anellipse that has had a segment removed.

In an application, the tissue anchor is stored in the anchor-storagezone in a given rotational orientation of the tissue anchor with respectto the opening, the anchor-engaging head is couplable to the tissueanchor in not all rotational orientations of the head with respect tothe tissue anchor, and the anchor-engaging head is couplable to thetissue anchor without rotating the anchor-engaging head subsequently tointroducing the anchor-engaging head through the opening.

In an application, the opening limits the range of rotationalorientations such that the anchor-engaging head is introducible throughthe opening in only a given rotational orientation of the head withrespect to the opening.

In an application, the apparatus further includes a base, and:

the housing is couplable to the base,

the base is configured to at least partly immobilize the housing, and

the base is shaped to define a receptacle for housing and at leastpartly immobilizing the handle.

In an application, when the housing is coupled to the base, the housingis disposed less than 30 cm from the receptacle.

In an application:

the receptacle is a handle receptacle,

the housing is reversibly couplable to the base,

the base is shaped to further define a housing receptacle, configured tohouse the housing,

the base further includes a locking element, movable between a lockedstate that locks the housing within the receptacle, and an unlockedstate that facilitates release of the housing from the receptacle.

In an application, the adjuster is operable while the receptacle housesthe handle.

In an application, the apparatus is configured such that while thereceptacle houses the handle, a human operator may:

with a first hand of the operator, grasp a distal portion of the driverand introduce the head into the opening, and

with a second hand of the operator, reversibly actuate the head byoperating the adjuster while grasping the distal portion of the driverwith the first hand.

There is further provided, in accordance with an application of thepresent invention, apparatus for use with an anchor driver, theapparatus including:

a housing, shaped to define a channel having (a) an anchor-storage zoneand (b) a proximal opening configured to provide access for the anchordriver to the anchor-storage zone;

a tissue anchor, slidable through the channel and configured to bestored in the anchor-storage zone; and

a retaining member:

-   -   having a retaining state in which the retaining member is        configured to retain the tissue anchor in the anchor-storage        zone, and    -   being disposed within the housing such that sliding of the        tissue anchor proximally out of the anchor-storage zone and        through the channel causes the retaining member to slide in an        at least partly proximal direction.

In an application, the retaining member is disposed within the housingsuch that sliding of the tissue anchor proximally out of theanchor-storage zone and through the channel causes the retaining memberto slide along an axis that is disposed at an angle of less than 30degrees with respect to a central longitudinal axis of the channel.

There is further provided, in accordance with an application of thepresent invention, apparatus, including:

a housing, shaped to define a channel having an anchor-storage zone anda proximal opening;

an anchor driver including an anchor-engaging head, a handle, and ashaft therebetween, and:

-   -   the shaft is flexible and is configured to be transluminally        advanced into a subject, and    -   the anchor-engaging head is dimensioned to be advanceable        through the proximal opening toward the anchor-storage zone; and        a tissue anchor:    -   stored in the anchor-storage zone,    -   including (i) a coupling head configured to be locked to the        anchor-engaging head while the tissue anchor is in the        anchor-storage zone, and (ii) a tissue-engaging member        configured to be driven into tissue of the subject using the        anchor driver, and    -   configured such that, while stored in the anchor-storage zone,        the tissue anchor is movable out of the anchor-storage zone        toward the proximal opening only in response to a        proximally-directed force being applied to the tissue anchor,        the proximally-directed force being greater than a        pre-determined threshold force.

In an application, the tissue anchor is configured to be movable out ofthe anchor-storage zone only in response to the proximally-directedforce, by being dimensioned with respect to at least one dimension ofthe housing such that the tissue anchor is movable out of theanchor-storage zone only in response to the proximally-directed force.

There is further provided, in accordance with an application of thepresent invention, apparatus, including:

an anchor-handling device including a housing, shaped to define achannel having an anchor-storage zone and a proximal opening;

an anchor driver including an anchor-engaging head, a handle, and ashaft therebetween, and:

-   -   the shaft is flexible and is configured to be transluminally        advanced into a subject, and    -   the anchor-engaging head is dimensioned to be advanceable        through the proximal opening toward the anchor-storage zone; and        a tissue anchor:    -   stored in the anchor-storage zone,    -   including (i) a coupling head configured to be locked to the        anchor-engaging head while the tissue anchor is in the        anchor-storage zone, and (ii) a tissue-engaging member        configured to be driven into tissue of the subject using the        anchor driver, and    -   configured such that, while stored in the anchor-storage zone,        the tissue anchor is movable out of the anchor-storage zone        toward the proximal opening in response to a proximally-directed        force being applied to the tissue anchor by the anchor driver,

and the anchor-handling device is configured to provide an indication ofthe movement of the tissue anchor out of the anchor-storage zone towardthe proximal opening in response to the proximally-directed force.

In an application, the anchor-handling device is configured to providethe indication by the housing being at least in part transparent, suchthat the movement of the tissue anchor is viewable from outside thehousing.

In an application, the anchor-handling device is configured to providethe indication by including an element that moves with respect to thehousing in response to the movement of the tissue anchor.

In an application, the element that moves with respect to the housingmoves out of the housing in response to the movement of the tissueanchor.

In an application, the element that moves with respect to the housingmoves with respect to the housing at a rate that is relative to a rateat which the anchor moves with respect to the housing.

The present invention will be more fully understood from the followingdetailed description of applications thereof, taken together with thedrawings, in which:

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-F are schematic illustrations of an anchor-handling device,configured to facilitate handling of at least one tissue anchor, inaccordance with some applications of the invention;

FIG. 2 is a schematic illustration of a multiple-anchor-handling device,in accordance with some applications of the invention;

FIGS. 3A-C are schematic illustrations of a system for transcatheterdelivery of an implant, and anchoring of the implant using an anchordriver and a plurality of anchors provided in themultiple-anchor-handling device of FIG. 2, in accordance with someapplications of the invention;

FIGS. 4A-F are schematic illustrations of an anchor-handling device,configured to facilitate handling of at least one tissue anchor, inaccordance with some applications of the invention; and

FIGS. 5A-C are schematic illustrations of a base to which ananchor-handling device is couplable, and which is configured to at leastpartly immobilize the anchor-handling device, in accordance with someapplications of the invention.

DETAILED DESCRIPTION OF EMBODIMENTS

Reference is made to FIGS. 1A-F, which are schematic illustrations of ananchor-handling device 20, configured to facilitate handling of at leastone tissue anchor 40, in accordance with some applications of theinvention. Device 20 comprises a housing 22 that defines a channel 24,an anchor-storage zone 26 (e.g., at a distal end of the channel) and anopening 28 (e.g., at a proximal end of the channel) that provides accessto the channel and the anchor-storage zone. Typically, there is a smoothtransition between anchor-storage zone 26 and channel 24. Device 20further comprises a retaining member, such as a pin 30, which isconfigured to retain tissue anchor 40 in zone 26, and to stop retainingthe tissue anchor in response to a sufficient proximally-directed forceapplied to the tissue anchor. That is, when a proximally-directed forcethat is greater than a predetermined threshold force is applied totissue anchor 40, the retaining member stops retaining (e.g., releases)the tissue anchor.

Typically, the retaining member (e.g., pin 30) has a retaining state inwhich it retains tissue anchor 40 within zone 26, and is moved out theretaining state when the sufficient proximally-directed force is appliedto the tissue anchor. FIG. 1A shows, in accordance with someapplications of the invention, pin 30 in a retaining state thereof, inwhich at least a portion 29 (e.g., an obstructing portion, and/or adistal portion) of the pin is disposed within channel 24 (e.g., proximalto anchor 40), thereby retaining the anchor in zone 26 by obstructingproximal movement of the tissue anchor. Typically, portion 29 obstructsproximal movement of anchor 40 by engaging and/or obstructing core 41 ofthe anchor (described hereinbelow).

It is to be noted that although pin 30 is shown as being generallycylindrical (i.e., having a generally circular transversecross-section), the term “pin”, as used throughout the presentapplication, including the specification and the claims, may include apin having a different shape (e.g., having a noncircular transversecross-section). For example, pin 230 (described hereinbelow withreference to FIGS. 4A-5C) typically has a rectangular cross-section.

FIG. 1A shows an anchor driver 60 being advanced toward opening 28 ofchannel 24, and FIG. 1B shows the anchor driver having been furtheradvanced into and through channel 24, to anchor 40. As more clearlyshown in FIGS. 1A and 1F, opening 28 is typically beveled (i.e.,disposed at an angle smaller than 90 degrees to a longitudinal axis ofchannel 24), such that the opening has a greater area than does atransverse cross section of the channel, thereby facilitatingintroduction of driver 60 into the channel. It is to be noted that theshape of opening 28 provides a proximal region 25 in which channel 24 isat least half open on a lateral side (i.e., at least half of thecircumferential surface of the channel is missing). This shape therebyfacilitates placement of a driver head 62 of driver 60 in proximalregion 25 of channel 24, e.g., by reducing a requirement for the driverto be aligned with the channel before its introduction into the channel.Driver 60 (e.g., head 62 thereof) can subsequently be advanced furtherinto channel 24, using region 25 as a guide track.

Driver 60 typically comprises an anchor-engaging head 62 at a distal endof the driver, and a shaft 64 proximal to the anchor-engaging head.Shaft 64 is flexible and advanceable (e.g., transcatheterally) throughvasculature of a subject, and typically has a length greater than 20 cm,and/or less than 2.5 m, such as greater than 50 cm and/or less than 1.5m, e.g., between 0.9 m and 1.2 m. For some applications, driver 60comprises a handle 66 at a proximal end of shaft 64, the handlecomprising an adjuster 68 (e.g., a switch or a lever) configured toactuate engaging head 62.

Tissue anchor 40 typically comprises a core 41, a tissue-engaging member44 coupled to a distal side of the core, and a coupling head 42 coupledto a proximal side of the core. Engaging head 62 is configured to bereversibly couplable to tissue anchor 40 (e.g., to coupling head 42thereof), so as to facilitate acquisition of the anchor from device 20,driving of the anchor into tissue of the subject, and subsequent releaseof the anchor and withdrawal of driver 60 from the subject. For example,actuation of engaging head 62 by adjuster 68 may comprise transitioningthe engaging head between (i) an open state in which the engaging headis configured to receive and/or release anchor 40 (FIGS. 1A-B), and (ii)a closed state in which the engaging head, having received the anchor(FIG. 1C), is coupled (e.g., locked) to the anchor.

FIG. 1B shows engaging head 62 having received anchor 40, but not yetcoupled (e.g., locked) to the anchor. It is to be noted that in thisposition part of driver 60 (e.g., head 62) is disposed (e.g.,sandwiched) between part of the retaining member (e.g., portion 29) andpart of the anchor (e.g., coupling head 42).

FIG. 1C shows engaging head 62 being coupled (e.g., locked) to anchor40. For some applications of the invention, engaging head 62 comprises adetent 70 that is transitioned into the closed state when a controller,such as a rod or a wire 72, is moved distally by adjuster 68, andautomatically transitions back into the open state when the wire iswithdrawn. FIG. 1C shows wire 72 having been moved distally intoengaging head 62, and detent 70 having been pushed into the closedstate, thereby coupling the engaging head to anchor 40 (e.g., tocoupling head 42 thereof).

FIGS. 1D-E show anchor 40 being withdrawn proximally from zone 26 ofchannel 24 by the sufficient proximally-directed force being applied tothe anchor by driver 60. As described hereinabove, in response to thesufficient proximally-directed force applied to the tissue anchor (i.e.,if the proximally-directed force is greater than the pre-determinedthreshold force), the retaining member (e.g., pin 30) stops retainingthe tissue anchor in zone 26. For example, and as shown in FIGS. 1D-E,the sufficient proximally-directed force overcomes the retentionprovided by pin 30 and pushes portion 29 of pin 30 out of the channeland into a chamber 74 that is in fluid communication with the channel(at least part of pin 30 thereby sliding within the chamber).

It is hypothesized that this configuring of device 20 to require thatthe sufficient proximally-directed force be applied to tissue anchor 40prevents inadvertent movement and/or exit of the tissue anchor (e.g.,due to general transport or handling of the device), and/or withdrawalof the anchor by driver 60 when the driver is sub-optimally coupled tothe anchor.

For some applications, a first end 76 of chamber 74 is in fluidcommunication with channel 24, housing 22 defines an opening 78 at asecond end of the chamber, and the pushing of portion 29 of pin 30 bythe sufficient proximally-directed force pushes a second (e.g.,proximal) portion 31 of the pin out of opening 78. This feature andadvantages thereof are described in more detail hereinbelow. Typically,chamber 74 has a proximal-distal longitudinal axis that is disposed atbetween 5 and 30 degrees, e.g., 5-20 degrees (e.g., 5-15 degrees or10-20 degrees, such as between 11 and 14 degrees) with respect to thelongitudinal axis of channel 24. It is hypothesized that, for someapplications, this angular disposition of the channel and chamberfacilitates the above described movement of pin 30 in response to thesufficient proximally-directed force applied to the tissue anchor.

FIG. 1F shows anchor 40 having been fully withdrawn out of channel 24via opening 28. Once anchor 40 has been fully withdrawn, driver 60 maybe used to anchor tissue anchor 40 to tissue of a subject, e.g., bydriving tissue-engaging member 44 (FIG. 1A) of the anchor into thetissue. It may be used as a tissue anchor as is known in the art. Forexample, using driver 60, anchor 40 may be advanced through atransluminal implant-delivery system and used to couple an implant totissue of a subject, e.g., as described hereinbelow with reference toFIGS. 3A-C.

For some applications, device 20 comprises an inhibitor, configured toconfigure the retaining member (e.g., pin 30) to (i) retain the tissueanchor in anchor-storage zone 26, and (ii) to stop retaining the tissueanchor in response to the sufficient proximally-directed force. Forexample, the inhibitor may comprise an inhibitor tongue 80, that has apin-contacting portion 82 (e.g., a pin-contacting surface) that is incontact with pin 30, and that provides resistance that (i) inhibitssliding of the pin through chamber 74 (e.g., prevents sliding of the pinin response to an insufficient proximally-directed force, i.e., aproximally-directed force that is less than the pre-determined thresholdforce), and (ii) allows sliding of the pin through the chamber inresponse to the sufficient proximally-directed force that is greaterthan the pre-determined threshold force being applied to tissue anchor40. Pin-contacting portion 82 is typically held in contact with pin 30by a spring mechanism. For example, and as shown in FIGS. 1A-F,inhibitor tongue 80 may comprise an elastically-deformable (e.g.,shape-memory) material, and may be coupled to housing 22 by in a mannerin which the inhibitor tongue itself provides the spring mechanism.

For some applications, pin 30 defines a cavity 32 therein (e.g., arecess or a notch in a lateral side of the pin), in which pin-contactingportion 82 is typically disposed while anchor 40 is disposed withinanchor-storage zone 26 (e.g., in a state in which the device isprovided). For such applications, portion 82 serves as a detent. Forsuch applications, cavity 32 and inhibitor tongue 80 are configured suchthat when a proximally-directed force equal to or greater than thethreshold force is applied to anchor 40, pin 30 is pushed againstpin-contacting portion 82, and inhibitor tongue 80 responsively deformssuch that the pin-contacting portion moves out of cavity 32, allowingpin 30 to move further proximally (FIG. 1D). Typically, for suchapplications, once portion 82 has moved out of cavity 32, aproximally-directed force that is smaller than the threshold force issufficient to move pin 30 further proximally. That is, once the initialresistance provided by the inhibitor is overcome, anchor 40 is furtherwithdrawable using a smaller force than that required to overcome theinitial resistance.

(It will be understood by those skilled in the art that it is possibleto use other configurations to achieve a behavior similar to thatdescribed above. For example, housing 22 may define a cavity, and pin 30may comprise a flexible protrusion that extends into the cavity of thehousing.)

For some applications, the inhibitor (e.g., tongue 80) provides theresistance by applying friction against the retaining member (e.g., pin30). For example, pin-contacting portion 82 may comprise a high-frictionpin-contacting surface.

Reference is made to FIG. 2, which is a schematic illustration of amultiple-anchor-handling device 100, in accordance with someapplications of the invention. Device 100 defines a plurality ofchannels 24, each channel having a respective proximal opening 28 and arespective anchor-storage zone 26 that is configured to store arespective tissue anchor 40 (zone 26 and anchor 40 not visible in FIG.2). Typically, device 100 further comprises a plurality of retainingmembers (e.g., pins 30), each retaining member being configured toretain a respective tissue anchor in its respective anchor-storage zone26, and to stop retaining the respective tissue anchor in response tothe sufficient proximally-directed force being applied to its respectivetissue anchor. For some applications, device 100 comprises a pluralityof devices 20. For example, device 100 may comprise a plurality ofhousings 22, each housing defining exactly one channel 24 and exactlyone retaining member (e.g., pin 30).

As described hereinabove, for some applications, the sufficientproximally-directed force pushes a second (e.g., proximal) portion 31 ofpin 30 out of opening 78 of chamber 74. Therefore, when driver 60 iswithdrawn proximally, movement of portion 31 toward and/or out ofopening 78 indicates that anchor-engaging head 62 has been successfullycoupled to tissue anchor 40, and that the tissue anchor is also beingwithdrawn proximally. Thus, during an initial partial withdrawal ofdriver 60, movement of portion 31 toward and/or out of opening 78provides an indication to the operator (e.g., physician) to continue towithdraw driver 60, whereas absence of such movement of portion 31provides an indication to the operator to reattempt coupling of thedriver to tissue anchor 40.

Following removal of anchor 40 from channel 24, portion 31 remainsexposed from opening 78. This may be particularly useful for a physicianusing a multiple-anchor-handling device, such as device 100, e.g., toprevent the physician inadvertently attempting to obtain an anchor froman empty zone 26. That is, portion 31 functions as an empty-housingindicator.

For some applications, pin 30 defines a second cavity 34 therein (e.g.,a second notch in a lateral side of the pin), disposed closer to distalportion 29 than is cavity 32. Second cavity 34 is positioned such thatwhen (1) distal portion 29 is no longer obstructing anchor 40, and (2)second portion 31 is exposed out of opening 78, pin-engaging portion 82of inhibitor tongue 80 moves into the second cavity (e.g., as shown inFIG. 1E). In this state, tongue 80 inhibits pin 30 from moving distallyback into housing 22, thereby increasing the reliability of portion 31functioning as an empty-housing indicator. For some applications, and asshown in FIGS. 1A-F, second cavity 34 is shaped such that once portion82 has moved into (e.g., engaged) second cavity 34, the moving ofportion 31 back into housing 22 requires a distally-directed force thatis more than twice as great (in the opposite direction) as the thresholdforce that was previously required to move portion 31 out of thehousing. For example, the moving of portion 31 back into housing 22 maybe in effect prevented.

Reference is made to FIGS. 3A-C, which are schematic illustrations of amulti-component tubular system 120 for transcatheter delivery of animplant 140, and anchoring of the implant using anchor driver 60 and aplurality of anchors 40 provided in multiple-anchor-handling device 100,in accordance with some applications of the invention. Implant 140comprises an annuloplasty structure comprising a sleeve 142, a flexibleelongated contracting member 144 that extends along the sleeve, and anadjustment mechanism 146 which facilitates contracting and expanding ofthe annuloplasty structure. Typically, adjustment mechanism 146comprises a spool around which successive portions of member 144 arewound in order to contract the annuloplasty structure afterimplantation.

Implant 140 is configured to be anchored to an annulus 10 of a valve ofthe heart 12 of a subject, such as a mitral valve 14 of the subject, andto change a dimension of the annulus when contracted or expanded usingadjustment mechanism 146.

System 120 comprises one or more steerable catheters, and typicallycomprises an outer catheter 122 and an inner catheter 124 that isadvanceable through the outer catheter. Outer catheter 122 isadvanceable and steerable using a first handle 126, and inner catheter124 is advanceable and steerable using a second handle 128. Typically,second handle 128 is couplable (e.g., lockable) to first handle 126,e.g., after advancement of catheter 124 through catheter 122.

Implant 140 is typically (1) advanceable through inner catheter 124 in adelivery configuration in which adjustment mechanism 146 is disposed onan axis defined by sleeve 142, distally to a distal end 143 of thesleeve, and (2) transitionable into an anchoring configuration in whichthe adjustment mechanism is disposed laterally to the sleeve (FIG. 3Ashows implant 140 in the anchoring configuration thereof). Advancementof implant 140 distally out of catheter 14 is typically controllableusing a third handle 132 which is slidably coupled to handle 128, e.g.,via a handle-sliding track 138.

A portion of sleeve 142 (e.g., distal end 143) is placed against annulus10 (FIG. 3A). Typically, system 120 further comprises animplant-decoupling channel 130, disposed within sleeve 142, and slidableprogressively proximally out of the sleeve, e.g., using a knob 134coupled to a proximal end of channel 130. Typically, channel 130 is usedto hold the portion of sleeve 142 (e.g., distal end 143) against annulus10.

FIG. 3A shows anchor driver 60 (e.g., anchor-engaging head 62 thereof)being coupled to a first anchor 40 (not visible in FIG. 3A) which isdisposed within a first housing 22 of device 100, as describedhereinabove (e.g., with reference to FIGS. 1A-C). Subsequently, as shownin FIG. 3B, anchor driver 60 is withdrawn from the first housing 22 ofdevice 100, while coupled to anchor 40. Anchor 40 is then advanced intosystem 120 by advancing driver 60 (e.g., anchor-engaging head 62 andshaft 64 thereof) through the system (FIG. 3C). Typically, and as shownin FIG. 3C, the anchor is introduced into system 120 via a port 136 at aproximal end of handle 132, and is slid through channel 130, into sleeve142, and is screwed through sleeve 142 (e.g., distal end 143 thereof)and into annulus 10.

Driver 60 is subsequently removed from system 120, coupled to a secondanchor 40 disposed in a second housing 22 of device 100, andreintroduced into the system. Channel 130 is withdrawn slightlyproximally from the sleeve, and a second portion of the sleeve is heldagainst a second site on annulus 10 before the second anchor is driventhrough sleeve 142, anchoring the second portion of the sleeve to thesecond site. This process is repeated so as to place and anchor sleeve142 around at least a portion of annulus 10.

Typically, and as shown in FIGS. 3A-C, device 100 is coupled to system120 (e.g., the rest of system 120) so as to facilitate access by driver60 to openings 28 of channels 24 of housings 22. For example, device 100may be coupled to a stand (e.g., a base-plate) 121 of system 120, and/ormay be oriented such that openings 28 face generally the same directionas port 136 of system 120, such that the operator (e.g., a physician)may easily move driver 60 between openings 28 and port 136. Typically,device 100 is positioned such that openings 28 are closer than 1 mand/or greater than 1 cm (e.g., between 1 cm and 1 m, such as between 1cm and 70 cm, such as between 1 cm and 40 cm) away from port 136 (oranother opening through which anchors 40 are introduced into system120).

Alternatively, device 100 may comprise a standalone unit, not coupled tosystem 120 or any other system.

Subsequently, implant 140 may be adjusted (e.g., contracted) using anadjustment tool (not shown), advanceable over a guide member 141 toadjustment mechanism 146.

Reference is made to FIGS. 4A-F, which are schematic illustrations of ananchor-handling device 220, configured to facilitate handling of atleast one tissue anchor 40, in accordance with some applications of theinvention. Device 220 comprises a housing 222 that defines a channel 224having an anchor-storage zone 226 and an opening 228 that providesaccess to the channel and the anchor-storage zone. Device 220 furthercomprises a retaining member, such as a pin 230, which is configured toretain tissue anchor 40 in zone 226, and to stop retaining the tissueanchor in response to a sufficient proximally-directed force applied tothe tissue anchor. That is, when a proximally-directed force that isgreater than a pre-determined threshold force is applied to tissueanchor 40, the retaining member stops retaining (e.g., releases) thetissue anchor. For some applications FIGS. 4A-F, which show steps in theuse of device 220, generally correspond to FIGS. 1A-F, respectively,which show steps in the use of device 20, mutatis mutandis.

Typically, the retaining member (e.g., pin 230) has a retaining state inwhich it retains tissue anchor 40 within zone 226, and is moved out theretaining state when the sufficient proximally-directed force is appliedto the tissue anchor. FIG. 4A shows, in accordance with someapplications of the invention, pin 230 in a retaining state thereof, inwhich at least a portion 229 (e.g., an obstructing portion) of the pinis disposed within channel 224 (e.g., proximal to anchor 40), therebyretaining the anchor in zone 226 by obstructing proximal movement of thetissue anchor. Typically, portion 229 obstructs proximal movement ofanchor 40 by engaging and/or obstructing core 41 of the anchor. Anotherportion of pin 230 is disposed in a chamber 274, which is defined byhousing 222 and is typically in fluid communication with channel 224(e.g., in the absence of pin 230). Typically, chamber 274 has a centrallongitudinal axis ax1 that is parallel with a central longitudinal axisax2 of channel 24.

Similarly to device 20, it is hypothesized that this configuring ofdevice 220 prevents inadvertent movement and/or exit of the tissueanchor (e.g., due to general transport or handling of the device),and/or withdrawal of the anchor by driver 60 when the driver issub-optimally coupled to the anchor.

FIG. 4A shows anchor driver 60 (described hereinabove) being advancedtoward opening 228 of channel 224, and FIG. 4B shows the anchor driverhaving been further advanced into and through channel 224, to anchor 40,such that engaging head 62 has received anchor 40, but not yet coupled(e.g., locked) to the anchor. It is to be noted that in this positionpart of driver 60 (e.g., head 62) is disposed (e.g., sandwiched) betweenpart of the retaining member (e.g., portion 229) and part of the anchor(e.g., coupling head 42).

FIG. 4A shows respective cross-sections of opening 228 and driver head62, which are typically each rotationally asymmetrical. For someapplications, and as shown, the cross-sections each have the shape of anellipse (e.g., a circle) with a segment (e.g., a circular segment)removed. (For some applications opening 228 (e.g., the shape thereof) isdefined partly by housing 222, and partly by pin 230.) Due to thisrotational asymmetry, anchor-engaging head 62 is introducible throughopening 228 in fewer than all rotational orientations of the head withrespect to the opening. For example, head 62 may be introducible throughopening 228 only in one or more particular rotational orientations(e.g., one particular orientation of the head) of the head with respectto the opening. This limitation of the rotational orientations in whichhead 62 may be introduced through opening 228 causes the head to becorrectly rotationally oriented for coupling to coupling head 42 ofanchor 40, the anchor being stored in zone 226 in a given rotationalorientation with respect to the opening. Therefore anchor-engaging head62 is couplable to anchor 40, without rotating the anchor-engaging headsubsequently to introducing the anchor-engaging head through opening228.

It is to be noted that this orientation-limitation may be applied todevice 20, mutatis mutandis, and that the lateral channel opening thatprovides region 25 of device 20 may be applied to device 220, mutatismutandis.

FIG. 4C shows wire 72 having been moved distally into engaging head 62,and detent 70 having been pushed into the closed state, thereby couplingthe engaging head to anchor 40 (e.g., to coupling head 42 thereof).

FIGS. 4D-E show anchor 40 being withdrawn proximally from zone 226 bythe sufficient proximally-directed force being applied to the anchor bydriver 60. As described hereinabove, in response to the sufficientproximally-directed force applied to the tissue anchor (i.e., if theproximally-directed force is greater than the pre-determined thresholdforce), the retaining member (e.g., pin 230) stops retaining the tissueanchor in zone 226. For example, and as shown in FIGS. 4D-E, thesufficient proximally-directed force overcomes the retention provided bypin 230 such that at least a portion of pin 230 slides within chamber274, and at least a portion 231 (e.g., a proximal portion) of pin 230moves out of housing 222.

FIG. 4D shows portion 231 of pin 230 beginning to move out of housing222, and FIG. 4E shows both portion 231 and anchor 40 disposed outsideof the housing, such that pin 230 (e.g., portion 229 thereof) no longerobstructs anchor 40. It is to be noted that for device 220, the portion229 of pin 230 that obstructs anchor 40 is disposed close to (e.g.,within) the portion 231 of pin 230 that becomes exposed from housing222, whereas for device 20 described hereinabove, the portion 29 of pin30 that obstructs anchor 40 is disposed at another part (e.g., at theother end) of pin 30 from the portion 31 of pin 30 that becomes exposedfrom housing. Similarly, portion 229 typically becomes exposed fromhousing 222 upon withdrawal of anchor 40 from device 20, whereas portion29 typically remains within housing 22 upon withdrawal of anchor 40 fromdevice 220.

FIG. 4F shows anchor 40 having been fully removed from the housing. Forsome applications, to facilitate full disengagement of anchor 40 frompin 230, the anchor is moved slightly laterally with respect to pin 30.Once anchor 40 has been fully withdrawn, driver 60 may be used to anchortissue anchor 40 to tissue of a subject, e.g., as described hereinabove.

Device 220 comprises an inhibitor, configured to configure the retainingmember (e.g., pin 30) to (i) retain the tissue anchor in anchor-storagezone 26, and (ii) to stop retaining the tissue anchor in response to thesufficient proximally-directed force. For example, pin 230 may compriseor define a detent 282 that, while anchor 40 is disposed withinanchor-storage zone 226, is held by a spring mechanism within a cavity232 (e.g., a notch) defined in chamber 274, and thereby serves as theinhibitor. For some applications at least a portion 280 of pin 230 isresilient, and thereby provides the spring mechanism. It is to be noted,however, that the scope of the invention includes the use of otherspring mechanisms. The inhibitor provides resistance that (i) inhibitssliding of pin 230 through chamber 274, e.g., prevents sliding of thepin in the absence of a sufficient proximally-directed force (e.g., asshown in FIG. 4C), and (ii) stops inhibiting the sliding in response tothe sufficient proximally-directed force by detent 282 moving out ofcavity 232 (e.g., as shown in FIG. 4D). For example, and as shown,resilient portion 280 deforms (e.g., bends) in response to thesufficient proximally-directed force. This is typically facilitated bydetent 282 and a proximal wall of cavity 232 having respective facesthat are appropriately angled with respect to each other such that theproximally-directed force is converted into lateral movement of thedetent out of the cavity. For example, and as shown, detent 282 may havea beveled edge.

Typically, for such applications, once detent 282 has moved out ofcavity 232, a proximally-directed force that is smaller than thethreshold force is sufficient to move pin 30 further proximally. Thatis, once the initial resistance provided by the inhibitor is overcome,anchor 40 is further withdrawable using a smaller force than thatrequired to overcome the initial resistance.

(It will be understood by those skilled in the art that it is possibleto use other configurations to achieve a behavior similar to thatdescribed above. For example, housing 222 may define a protrusion (e.g.,a detent), and pin 30 may comprise a cavity (e.g., a notch) into whichthe protrusion extends.)

For some applications, the inhibitor provides the resistance by applyingfriction against the wall of cavity 232. For example, pin 230 may have ahigh-friction wall-contacting surface.

Device 220 is described hereinabove with reference to only one channel224, zone 226, and restraining member. Typically however, the devicedefines a plurality of channels 224, each channel having a respectiveproximal opening 228 and a respective anchor-storage zone 226 that isconfigured to store a respective tissue anchor 40 (e.g., as describedwith reference to device 100, mutatis mutandis). Typically, device 220further comprises a plurality of retaining members (e.g., pins 230),each retaining member being configured to retain a respective tissueanchor in its respective anchor-storage zone 226, and to stop retainingthe respective tissue anchor in response to the sufficientproximally-directed force being applied to its respective tissue anchor.

As described hereinabove, for some applications, the sufficientproximally-directed force pushes portion 231 of pin 30 out of housing222. Therefore, as driver 60 is withdrawn proximally, movement ofportion 231 out of housing 222 indicates that anchor-engaging head 62has been successfully coupled to tissue anchor 40, and that the tissueanchor is also being withdrawn proximally. Thus, during an initialpartial withdrawal of driver 60, movement of portion 231 out of housing222 provides an indication to the operator (e.g., physician) to continueto withdraw driver 60, whereas absence of such movement of portion 231provides an indication to the operator to reattempt coupling of thedriver to tissue anchor 40.

Following removal of anchor 40 from channel 224, portion 231 remainsexposed outside of housing 222. This may be particularly useful for aphysician using device 220, e.g., to prevent the physician inadvertentlyattempting to obtain an anchor from an empty anchor-storage zone 226.That is, portion 231 functions as an empty-housing indicator.

For some applications, a second cavity 234 is defined in chamber 274(e.g., a second notch in a wall of the chamber), disposed moreproximally with respect to housing 222 than is cavity 232. Second cavity234 is positioned such that when (1) portion 229 is no longerobstructing anchor 40, and (2) portion 231 is exposed out of opening278, detent 282 (i.e., the inhibitor) moves into the second cavity(e.g., as shown in FIG. 4E). In this state, the detent inhibits pin 230from moving distally back into housing 222, thereby increasing thereliability of portion 31 functioning as an empty-housing indicator.

For some applications, and as shown in FIGS. 1A-F, second cavity 234 isdimensioned and/or shaped such that once detent 282 has moved into(e.g., engaged) second cavity 234, a distally-directed force required toreturn portion 231 into housing 222 (e.g., to return device 220 into itsretaining state) is more than twice as great (in the opposite direction)as the threshold force that was previously required to move portion 231out of the housing, and to remove anchor 40 from the housing. Forexample, and as shown, cavity 234 may be greater in one or moredimensions (e.g., wider and/or deeper) than cavity 232. While detent 282is disposed in cavity 232, the beveled edge of the detent is partlyexposed from cavity 232, whereas while the detent is disposed in cavity234, the beveled edge is disposed entirely within the cavity. Othergeometric configurations may also be used to generate this effect. Forexample, only a proximal face of detent 282 may be beveled.

For some applications, housing 222 is at least in part transparent, soas to enable viewing of the coupling of driver 60 to anchor 40, and/orwithdrawal of the anchor from the housing.

Reference is made to FIGS. 5A-C, which are schematic illustrations of abase 300 to which device 220 (e.g., housing 222 thereof) is couplable,and which is configured to at least partly immobilize the housing, inaccordance with some applications of the invention. For someapplications, and as shown, more than one device 220 is couplable tobase 300. Similarly to devices 20 and 100, for some applications device220 is used with multi-component tubular system 120 (describedhereinabove). For such applications, anchor driver 60 (e.g.,anchor-engaging head 62 thereof) is coupled to an anchor 40, and thenadvanced into system 120 (e.g., via a port 136 at a proximal end ofhandle 132). As described hereinabove, shaft 64 is flexible, andtypically has a length greater than 20 cm, and/or less than 2.5 m, suchas greater than 50 cm and/or less than 1.5 m, e.g., between 0.9 m and1.2 m. Because of this flexibility and length, it may be difficult foran operator (e.g., a physician) to wield and operate handle driver 60(e.g., to couple head 62 to an anchor while retaining control of shaft64 and handle 66). Base 300 facilitates such handling by defining ahandle receptacle 302 for housing and at least partly immobilizinghandle 66.

Typically, base 300 is configured such that when device 220 (e.g.,housing 222 thereof) is coupled to the base, the housing is disposedless than 30 cm from receptacle 302 (e.g., less than 20 cm, e.g., lessthan 10 cm, such as less than 5 cm from the receptacle), and thereforeless than 30 cm from handle 66 when the handle is disposed in thereceptacle. Because shaft 64 is typically flexible, despite its lengthtypically being greater than (e.g., more than twice as great, e.g., morethan 5 times as great, such as 2-10 times as great as) the distancebetween device 220 and receptacle 302, driver head 62 is insertable intodevice 220 while handle 66 is disposed in receptacle 302.

For some applications, device 220 is permanently coupled to base 300(e.g., device 220 and base 330 may be integrated). For some applicationsdevice 220 is reversibly couplable to base 300. For example, base 300may further define at least one housing receptacle 304, configured tohouse device 220. For such applications, base 300 further comprises alocking element 306, movable between a locked state that locks thehousing within the receptacle, and an unlocked state that facilitatesrelease of the housing from the receptacle. For example, and as shown,locking element 306 may comprise one or more bars 308 that areadvanceable through a portion of base 300 so as to protrude into (e.g.,through) receptacle 304; and housing 222 is shaped to define arespective one or more recesses 310 dimensioned to mate with the bars.Advancing bars 308 into receptacle 304 while housing 222 is disposed inthe receptacle thereby locks the housing within the receptacle.

Typically, receptacle 302 is dimensioned such that adjuster 68 isoperable while the receptacle houses handle 66. This, along with theproximity of handle 66 to device 220, advantageously facilitates theoperator (i) with a first hand, grasping a distal portion of driver 60and introducing driver head 62 into the opening of housing 222, and (ii)with a second hand, reversibly actuating driver head 62 by operating theadjuster while grasping the distal portion of the driver with the firsthand (FIG. 5C; operator's hands not shown). It is hypothesized that thisadvantageously improves wielding and operation of driver 60 incombination with device 220.

For some applications, base 300 is coupled to system 120, e.g., asdescribed hereinabove for device 100 with respect to FIGS. 3A-C, mutatismutandis.

For some applications, base 300 does not define a handle receptacle, butinstead serves only to hold device 220.

For some applications, device 20, device 100, and/or device 220 is usedin combination with one or more techniques described in one or more ofthe following references, which are all incorporated herein byreference:

-   -   U.S. patent application Ser. No. 12/437,103 to Zipory et al.,        filed May 7, 2009, which published as U.S. 2010/0286767. For        example, (1) device 100 of the present application may be used        to facilitate the techniques described with reference to FIGS.        2-3 and/or 6A-12 of U.S. 2010/0286767 to Zipory et al., mutatis        mutandis; (2) anchor driver 60 of the present application may        comprise or correspond to anchor driver 68 and/or anchor        deployment manipulator 24 of U.S. 2010/0286767 to Zipory et al.,        mutatis mutandis; (3) tissue anchor 40 of the present        application may comprise or correspond to anchor 38 of U.S.        2010/0286767 to Zipory et al., mutatis mutandis; and/or (4)        implant 140 of the present application may comprise or        correspond to annuloplasty ring 22 of U.S. 2010/0286767 to        Zipory et al., mutatis mutandis.    -   U.S. patent application Ser. No. 12/689,635 to Zipory et al.,        filed Jan. 19, 2010, which published as U.S. 2010/0280604. For        example, (1) device 100 of the present application may be used        to facilitate the techniques described with reference to FIGS.        2-3 and/or 11A-17 of U.S. 2010/0280604 to Zipory et al., mutatis        mutandis; (2) anchor driver 60 of the present application may        comprise or correspond to anchor driver 68 and/or anchor        deployment manipulator 24 of U.S. 2010/0280604 to Zipory et al.,        mutatis mutandis; (3) tissue anchor 40 of the present        application may comprise or correspond to anchor 38 of U.S.        2010/0280604 to Zipory et al., mutatis mutandis; and/or (4)        implant 140 of the present application may comprise or        correspond to annuloplasty ring 22 of U.S. 2010/0280604 to        Zipory et al., mutatis mutandis.    -   PCT patent application IL2012/050451 to Sheps et al., filed Nov.        8, 2013, which published as WO 2013/069019. For example, (1)        device 100 of the present application may be used to facilitate        the techniques described with reference to FIGS. 14A-I of WO        2013/069019 to Sheps et al., mutatis mutandis; (2) system 120 of        the present application may comprise or correspond to system 10        of WO 2013/069019 to Sheps et al., mutatis mutandis; (3) anchor        driver 60 of the present application may comprise or correspond        to anchor deployment manipulator 61 and/or anchor driver 36 of        WO 2013/069019 to Sheps et al., mutatis mutandis; and/or (4)        implant 140 of the present application may comprise or        correspond to annuloplasty structure 222 and/or sleeve 26 of WO        2013/069019 to Sheps et al., mutatis mutandis.    -   PCT patent application IL2013/050860 to Sheps et al., titled        “Controlled steering functionality for implant-delivery tool”,        filed on Oct. 23, 2013, which published as WO 2014/064694. For        example, (1) device 100 of the present application may be used        to facilitate techniques described with reference to FIGS.        10A-I, 12A-14B, 18A-C, 21-28, 34, and 36 of this PCT application        titled “Controlled steering functionality for implant-delivery        tool”, mutatis mutandis; (2) system 120 of the present        application may comprise or correspond to system 10 of this PCT        application titled “Controlled steering functionality for        implant-delivery tool”, mutatis mutandis; anchor driver 60 of        the present application may comprise or correspond to anchor        deployment manipulator 61, anchor driver 36 and/or anchor driver        2338 of this PCT application titled “Controlled steering        functionality for implant-delivery tool”, mutatis mutandis;        and/or (4) implant 140 of the present application may comprise        or correspond to annuloplasty structure 222 and/or sleeve 26 of        this PCT application titled “Controlled steering functionality        for implant-delivery tool”, mutatis mutandis.    -   PCT patent application IL2013/050861 to Herman et al., titled        “Percutaneous tissue anchor techniques”, filed on Oct. 23, 2013,        which published as WO 2014/064695. For example, (1) device 100        of the present application may be used to facilitate the        techniques described with reference to FIGS. 9A-C and/or 13A-D        of this PCT application titled “Percutaneous tissue anchor        techniques”, mutatis mutandis; (2) tissue anchor 40 of the        present application may comprise or correspond to tissue anchor        40 of this PCT application titled “Percutaneous tissue anchor        techniques”, mutatis mutandis; and/or (3) anchor driver 60 of        the present application may comprise or correspond to anchor        driver 500, anchor driver 236, deployment manipulator 261, or        tool 80 of this PCT application titled “Percutaneous tissue        anchor techniques”, mutatis mutandis.

Reference is again made to FIGS. 1A-5C. Typically, the tissue anchor isdimensioned to fit snugly in the anchor-storage zone of the housing.Typically, the tissue anchor (e.g., core 41 thereof) is dimensioned toslide snugly through the channel of the housing, and for someapplications this snug sliding prevents tissue-engaging member 44 of theanchor from touching the housing (e.g., the wall of the channel) whenthe anchor moves through the channel. Typically, at least a portion ofthe pin is dimensioned to slide snugly through the chamber.

As described hereinabove, for some applications the obstructing portionof the retaining member of devices 20 and 220 obstructs tissue anchor 40by engaging core 41 of the anchor. The movement of the retaining memberin response to the proximally-directed force applied to the anchortypically moves the obstructing portion such that it does notsubsequently engage tissue-engaging member 44 of the anchor. Forexample, for device 20, portion 29 moves at least partly laterally outof the anchor-storage zone and/or channel 24 (such that element 44 canmove past portion 29 without being engaged by it), and for device 220,portion 229 moves longitudinally out of channel 224 (such that element44 can move past portion 229 without being engaged by it). It ishypothesized that for some applications this advantageously reduces alikelihood of the anchor-handling device (e.g., the obstructing portionof the retaining member) damaging tissue-engaging member 44. It ishypothesized that the use of a retaining member that has an obstructingportion that returns to its original position as soon as core 41 hasmoved past the obstructing portion, does not have this advantageousfeature.

It is to be noted that the technique used to inhibit movement of theretaining member of device 20 may be used to inhibit movement of theretaining member of device 220, mutatis mutandis, and vice versa.

Reference is again made to FIGS. 1A-5C. It is to be noted that, for bothdevice 20 and device 220, proximal withdrawal of anchor 40 typicallyresults in sliding of the retaining member (e.g., the pin) in an atleast partly proximal direction. This sliding is typically along an axisthat is disposed at and angle of less than 30 degrees with respect to acentral longitudinal axis of the channel through which the anchor iswithdrawn. For example, for device 20 the angle is typically 8-30degrees (e.g., 10-20 degrees, such as 11-14 degrees), and for device 220the angle is typically less than 10 degrees, such as 0 degrees—i.e.,parallel with the channel.

Reference is again made to FIGS. 1A-5C. As described hereinabove, theanchor-handling devices allow retrieval of the tissue anchor(s) disposedtherein in response to a proximally-directed force that is greater thana threshold force. Typically the threshold force is greater than 300grams force and/or less than 1500 grams force (e.g., 300-1500 gramsforce, e.g., 500-1200 grams force, e.g., 500-1000 grams force, such as600-800 grams force). Tissue anchor 40 typically has a mass of less than1 g and/or greater than 0.01 g (e.g., 0.01-1 g, e.g., 0.05-0.2 g, e.g.,0.07-0.12 g, such as about 0.1 g). Thus the threshold force (measured ingrams force) is typically greater than 300 times (e.g., greater than1000 times, e.g., greater than 3000 times, e.g., greater than 10,000times, such as greater than 15,000 times) and/or less than 150,000 timesthe mass of the tissue anchor (measured in grams). It is to be notedthat the threshold force is therefore many times greater than that whichwould be required simply to prevent the tissue anchor from undesirablyexiting the device due to gravity and/or movement of the device (e.g.,during transport).

This configuration of the anchor-handling device serves to test couplingof the anchor driver to the tissue anchor before releasing the tissueanchor. Only if the coupling is sufficient to support aproximally-directed force that is greater than the threshold force, willthe device release the anchor. This is hypothesized to increase safetyand reliability of the use of the anchor and driver, e.g., by reducing alikelihood that the anchor will subsequently become disengaged from thedriver at an undesired time (e.g., within the body of a subject).Whereas one might consider testing the anchor-driver couplingsubsequently to removal of the anchor from the anchor-handling device,such post-removal testing requires an extra procedural step, and forsome applications it increases a likelihood of damaging and/orcontamination of the (typically sterile) tissue anchor. Furthermore,whereas the anchor-handling devices described herein facilitate making asecond attempt at coupling the driver to the same anchor, post-removaltesting typically does not.

Reference is again made to FIGS. 1A-5C. Typically the anchors areprovided sterile within the anchor-handling device. As describedhereinabove, for some applications, the anchor-handling device isconfigured such that returning the exposed portion of the retainingmember back into the housing requires a distally-directed force that ismore than twice as great (in the opposite direction) as the thresholdforce that was previously required to move the portion out of thehousing. For example, the moving of the portion back into the housingmay be in effect prevented. As well as facilitating the exposed portionserving as an empty-housing indicator, this characteristic of theanchor-handling device discourages and/or prevents the operator fromreturning a previously-removed anchor into the device, e.g., therebyensuring that only sterile anchors are disposed within the device.

For some applications, the anchor-handling devices described herein areconfigured to be at least in part submerged in saline prior to and/orduring use, e.g., to reduce a likelihood of air (e.g., bubbles) beingretained by the anchor and/or driver and subsequently introduced intothe subject.

It will be appreciated by persons skilled in the art that the presentinvention is not limited to what has been particularly shown anddescribed hereinabove. Rather, the scope of the present inventionincludes both combinations and subcombinations of the various featuresdescribed hereinabove, as well as variations and modifications thereofthat are not in the prior art, which would occur to persons skilled inthe art upon reading the foregoing description.

The invention claimed is:
 1. A system comprising: an anchor driver; ahousing, shaped to define a channel having an anchor-storage zone and aproximal opening configured to provide access for the anchor driver tothe anchor-storage zone; a tissue anchor, stored in the anchor-storagezone and slidable through the channel; and a retaining member: having aretaining state in which the retaining member is configured to retainthe tissue anchor in the anchor-storage zone, and being configured, bymoving in response to a proximally-directed force applied to the tissueanchor, to allow the tissue anchor to leave the anchor-storage zone inresponse to the proximally-directed force, the proximally-directed forcebeing greater than a pre-determined threshold force; wherein the tissueanchor has a mass, and the retaining member is configured such that thethreshold force, measured in grams force, is more than 1000 timesgreater than the mass of the tissue anchor, measured in grams.
 2. Thesystem according to claim 1, is configured such that after removal ofthe tissue anchor from the housing, a distally-directed force requiredto return the retaining member to the retaining state is more than twiceas great as the threshold force.
 3. The system according to claim 1,wherein the retaining member is configured such that the threshold forceis greater than 300 grams force.
 4. The system according to claim 1,wherein, in the retaining state, at least a portion of the retainingmember obstructs proximal movement of the tissue anchor by beingdisposed within the channel.
 5. The system according to claim 4, whereinin the retaining state, the anchor driver is slidable through thechannel and lockable to the tissue anchor while at least the portion ofthe retaining member obstructs proximal movement of the tissue anchor bybeing disposed within the channel.
 6. The system according to claim 5,wherein in the retaining state, the anchor driver is slidable throughthe channel such that a part of the anchor driver becomes positionedbetween a part of the tissue anchor and a part of the retaining member,and the anchor driver is lockable to the tissue anchor only while thepart of the anchor driver is positioned between the part of the tissueanchor and the part of the retaining member.
 7. The system according toclaim 4, wherein: the housing is shaped to define a chamber that is influid communication with the channel, at least part of the retainingmember is configured to slide within the chamber in response to theproximally-directed force applied to the tissue anchor, and theretaining member is configured such that, in response to theproximally-directed force applied to the tissue anchor, a second portionof the retaining member moves out of the housing.
 8. The systemaccording to claim 7, wherein: the retaining member comprises a pin,configured to slide through the chamber, the housing is shaped to definea chamber that is in fluid communication with the channel, at least partof the retaining member is configured to slide within the chamber inresponse to the proximally-directed force applied to the tissue anchor,the housing is shaped to define a cavity that is in fluid communicationwith the chamber, at least a portion of the retaining member isresilient, the retaining member is shaped to define a detent, in theretaining state, the resilience of at least the portion of the retainingmember holds the detent within the cavity, and the retaining member isconfigured to deform in response to the proximally-directed forceapplied to the tissue anchor, such that the detent exits the cavity. 9.The system according to claim 8, wherein: the cavity comprises a firstcavity, the housing is shaped to define a second cavity that is in fluidcommunication with the chamber, and the system is dimensioned such thatwhen the retaining member allows the tissue anchor to leave theanchor-storage zone, further proximal movement of the retaining membercauses the detent to move into the second cavity.
 10. The systemaccording to claim 9, wherein the second cavity is larger in at leastone dimension than the first cavity.
 11. The system according to claim9, wherein the second cavity is differently shaped to the first cavity.12. The system according to claim 9, wherein the second cavity and thedetent are dimensioned such that when the detent is disposed within thesecond cavity, a distally-directed force required to return theretaining member to the retaining state is more than twice as great asthe threshold force.
 13. The system according to claim 7, wherein thechamber is in fluid communication with the channel at a distal end ofthe chamber, and has a proximal-distal longitudinal axis that isdisposed at between 5 and 30 degrees from a proximal-distal longitudinalaxis of the channel.
 14. The system according to claim 4, wherein: thehousing is shaped to define a chamber that is in fluid communicationwith the channel, at least part of the retaining member is configured toslide within the chamber in response to the proximally-directed forceapplied to the tissue anchor, and a central longitudinal axis of thechamber is parallel with a central longitudinal axis of the channel. 15.The system according to claim 1, wherein the anchor driver comprises: ata distal end thereof, an anchor-engaging head introducible through theopening of the housing and actuatable to be reversibly coupled to thetissue anchor; at a proximal end thereof, a handle comprising anadjuster configured to actuate the anchor-engaging head; and a flexibleshaft: disposed between the distal end of the anchor driver and theproximal end of the anchor driver, having a length of 50-250 cm, andconfigured to be transcatheterally advanced through vasculature of asubject.
 16. The system according to claim 15, wherein the opening ofthe housing is rotationally asymmetrical, a transverse cross-section ofthe anchor-engaging head is rotationally asymmetrical, and the openinglimits a range of rotational orientations of the anchor-engaging headwith respect to the opening in which the anchor-engaging head isintroducible through the opening.
 17. The system according to claim 16,wherein the tissue anchor is stored in the anchor-storage zone in agiven rotational orientation of the tissue anchor with respect to theopening, the anchor-engaging head is couplable to the tissue anchor innot all rotational orientations of the head with respect to the tissueanchor, and the anchor-engaging head is couplable to the tissue anchorwithout rotating the anchor-engaging head subsequently to introducingthe anchor-engaging head through the opening.
 18. The system accordingto claim 16, wherein the opening limits the range of rotationalorientations such that the anchor-engaging head is introducible throughthe opening in only a given rotational orientation of the head withrespect to the opening.
 19. The system according to claim 15, furthercomprising a base, wherein: the housing is couplable to the base, thebase is configured to at least partly immobilize the housing, and thebase is shaped to define a receptacle for housing and at least partlyimmobilizing the handle such that the adjuster remains operable.
 20. Thesystem according to claim 19, wherein when the housing is coupled to thebase, the housing is disposed less than 30 cm from the receptacle.
 21. Asystem comprising: an anchor driver; a housing, shaped to define achannel having an anchor-storage zone and a proximal opening configuredto provide access for the anchor driver to the anchor-storage zone; atissue anchor, stored in the anchor-storage zone and slidable throughthe channel; and a retaining member: having a retaining state in whichthe retaining member is configured to retain the tissue anchor in theanchor-storage zone, being configured, by moving in response to aproximally-directed force applied to the tissue anchor, to allow thetissue anchor to leave the anchor-storage zone in response to theproximally-directed force, the proximally-directed force being greaterthan a pre-determined threshold force, and being configured such thatthe threshold force is greater than 300 grams force.
 22. The systemaccording to claim 21, wherein the tissue anchor has a mass, and theretaining member is configured such that the threshold force, measuredin grams force, is more than 1000 times greater than the mass of thetissue anchor, measured in grams.
 23. A system comprising: an anchordriver; a housing, shaped to define a channel having an anchor-storagezone and a proximal opening configured to provide access for the anchordriver to the anchor-storage zone; a tissue anchor, stored in theanchor-storage zone and slidable through the channel; and a retainingmember: having a retaining state in which the retaining member isconfigured to retain the tissue anchor in the anchor-storage zone, andbeing configured, by moving in response to a proximally-directed forceapplied to the tissue anchor, to allow the tissue anchor to leave theanchor-storage zone in response to the proximally-directed force, theproximally-directed force being greater than a pre-determined thresholdforce, wherein: in the retaining state, at least a portion of theretaining member obstructs proximal movement of the tissue anchor bybeing disposed within the channel, the housing is shaped to define achamber that is in fluid communication with the channel, at least partof the retaining member is configured to slide within the chamber inresponse to the proximally-directed force applied to the tissue anchor,the retaining member is configured such that, in response to theproximally-directed force applied to the tissue anchor, a second portionof the retaining member moves out of the housing, the housing is shapedto define a cavity that is in fluid communication with the chamber, atleast a portion of the retaining member is resilient, the retainingmember is shaped to define a detent, in the retaining state, theresilience of at least the portion of the retaining member holds thedetent within the cavity, and the retaining member is configured todeform in response to the proximally-directed force applied to thetissue anchor, such that the detent exits the cavity.
 24. The systemaccording to claim 23, wherein the retaining member is configured suchthat the threshold force is greater than 300 grams force.
 25. The systemaccording to claim 23, wherein the tissue anchor has a mass, and theretaining member is configured such that the threshold force, measuredin grams force, is more than 1000 times greater than the mass of thetissue anchor, measured in grams.
 26. The system according to claim 23,wherein: the cavity comprises a first cavity, the housing is shaped todefine a second cavity that is in fluid communication with the chamber,and the system is dimensioned such that when the retaining member allowsthe tissue anchor to leave the anchor-storage zone, further proximalmovement of the retaining member causes the detent to move into thesecond cavity.
 27. The system according to claim 26, wherein the secondcavity is larger in at least one dimension than the first cavity. 28.The system according to claim 26, wherein the second cavity isdifferently shaped to the first cavity.
 29. The system according toclaim 26, wherein the second cavity and the detent are dimensioned suchthat when the detent is disposed within the second cavity, adistally-directed force required to return the retaining member to theretaining state is more than twice as great as the threshold force. 30.A system comprising: an anchor driver; a housing, shaped to define achannel having an anchor-storage zone and a proximal opening configuredto provide access for the anchor driver to the anchor-storage zone; atissue anchor, stored in the anchor-storage zone and slidable throughthe channel; and a retaining member: having a retaining state in whichthe retaining member is configured to retain the tissue anchor in theanchor-storage zone, and being configured, by moving in response to aproximally-directed force applied to the tissue anchor, to allow thetissue anchor to leave the anchor-storage zone in response to theproximally-directed force, the proximally-directed force being greaterthan a pre-determined threshold force, wherein: in the retaining state,at least a portion of the retaining member obstructs proximal movementof the tissue anchor by being disposed within the channel, the housingis shaped to define a chamber that is in fluid communication with thechannel, at least part of the retaining member is configured to slidewithin the chamber in response to the proximally-directed force appliedto the tissue anchor, the retaining member is configured such that, inresponse to the proximally-directed force applied to the tissue anchor,a second portion of the retaining member moves out of the housing, andthe chamber is in fluid communication with the channel at a distal endof the chamber, and has a proximal-distal longitudinal axis that isdisposed at between 5 and 30 degrees from a proximal-distal longitudinalaxis of the channel.